Biomarkers That Predict Response to High-Dose Aldesleukin in Patients With Metastatic Kidney Cancer or Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00617799|
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : April 2, 2018
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at biomarkers that predict response to high-dose aldesleukin in patients with metastatic kidney cancer or metastatic melanoma.
|Condition or disease||Intervention/treatment|
|Kidney Cancer Melanoma (Skin)||Biological: aldesleukin Genetic: gene expression analysis Genetic: mutation analysis Other: flow cytometry|
- Determine the relationship of peripheral blood lymphocyte phenotype pattern in patients with metastatic renal cell carcinoma or metastatic melanoma to response to high-dose aldesleukin (IL-2).
- Determine the relationship of peripheral blood mononuclear cells gene microarray patterns in patients with metastatic renal cell carcinoma or metastatic melanoma to response to high-dose IL-2.
- Determine the frequency of mutations on genes encoding for IL-2 receptor A and B.
OUTLINE: Patients receive high-dose aldesleukin (IL-2) as part of standard treatment on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline, prior to beginning course 2, and 4 weeks after the completion of course 2. Samples are analyzed using peripheral blood cytometry, gene microarray analysis, and IL-2 receptor single-nucleotide polymorphism techniques.
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|Official Title:||Pilot Study to Identify Biomarkers That May Predict Response to High Dose IL-2|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||February 18, 2009|
|Actual Study Completion Date :||April 16, 2010|
- Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2)
- Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2
- Frequency of mutations on genes encoding IL-2 receptor A and B
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617799
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-6805|
|Principal Investigator:||Ralph Hauke, MD||University of Nebraska|